EP2349382B1 - Herzunterstützungsgerät und system - Google Patents

Herzunterstützungsgerät und system Download PDF

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Publication number
EP2349382B1
EP2349382B1 EP09819466.5A EP09819466A EP2349382B1 EP 2349382 B1 EP2349382 B1 EP 2349382B1 EP 09819466 A EP09819466 A EP 09819466A EP 2349382 B1 EP2349382 B1 EP 2349382B1
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EP
European Patent Office
Prior art keywords
heart
energy
force
plate
patient
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EP09819466.5A
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English (en)
French (fr)
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EP2349382A1 (de
EP2349382A4 (de
Inventor
Peter Forsell
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MedicalTree Patents Ltd
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MedicalTree Patents Ltd
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Priority to EP19214928.4A priority Critical patent/EP3689318A1/de
Publication of EP2349382A1 publication Critical patent/EP2349382A1/de
Publication of EP2349382A4 publication Critical patent/EP2349382A4/de
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/3627—Heart stimulators for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/018—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor for receiving instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A—HUMAN NECESSITIES
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    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/04—Artificial pneumothorax apparatus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3627—Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
    • A—HUMAN NECESSITIES
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    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/148—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
    • A—HUMAN NECESSITIES
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    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A61M60/191—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart mechanically acting upon the outside of the patient's native heart, e.g. compressive structures placed around the heart
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    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/289—Devices for mechanical circulatory actuation assisting the residual heart function by means mechanically acting upon the patient's native heart or blood vessel structure, e.g. direct cardiac compression [DCC] devices
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    • A61M60/465—Details relating to driving for devices for mechanical circulatory actuation
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    • A—HUMAN NECESSITIES
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    • A61M60/465—Details relating to driving for devices for mechanical circulatory actuation
    • A61M60/47—Details relating to driving for devices for mechanical circulatory actuation the force acting on the actuation means being mechanical, e.g. mechanically driven members clamping a blood vessel
    • A61M60/473—Details relating to driving for devices for mechanical circulatory actuation the force acting on the actuation means being mechanical, e.g. mechanically driven members clamping a blood vessel generated by an electromotor
    • A61M60/476—Details relating to driving for devices for mechanical circulatory actuation the force acting on the actuation means being mechanical, e.g. mechanically driven members clamping a blood vessel generated by an electromotor with means converting the rotation into a translational movement of the displacement member
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    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40—Details relating to driving
    • A61M60/465—Details relating to driving for devices for mechanical circulatory actuation
    • A61M60/47—Details relating to driving for devices for mechanical circulatory actuation the force acting on the actuation means being mechanical, e.g. mechanically driven members clamping a blood vessel
    • A61M60/473—Details relating to driving for devices for mechanical circulatory actuation the force acting on the actuation means being mechanical, e.g. mechanically driven members clamping a blood vessel generated by an electromotor
    • A61M60/476—Details relating to driving for devices for mechanical circulatory actuation the force acting on the actuation means being mechanical, e.g. mechanically driven members clamping a blood vessel generated by an electromotor with means converting the rotation into a translational movement of the displacement member
    • A61M60/478—Details relating to driving for devices for mechanical circulatory actuation the force acting on the actuation means being mechanical, e.g. mechanically driven members clamping a blood vessel generated by an electromotor with means converting the rotation into a translational movement of the displacement member the axis of both movements being parallel, e.g. roller screw actuators or cylindrical cam transmissions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40—Details relating to driving
    • A61M60/465—Details relating to driving for devices for mechanical circulatory actuation
    • A61M60/489—Details relating to driving for devices for mechanical circulatory actuation the force acting on the actuation means being magnetic
    • A61M60/495—Electromagnetic force
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50—Details relating to control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50—Details relating to control
    • A61M60/508—Electronic control means, e.g. for feedback regulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50—Details relating to control
    • A61M60/508—Electronic control means, e.g. for feedback regulation
    • A61M60/515—Regulation using real-time patient data
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/861—Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/865—Devices for guiding or inserting pumps or pumping devices into the patient's body
    • A61M60/867—Devices for guiding or inserting pumps or pumping devices into the patient's body using position detection during deployment, e.g. for blood pumps mounted on and driven through a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/871—Energy supply devices; Converters therefor
    • A61M60/873—Energy supply devices; Converters therefor specially adapted for wireless or transcutaneous energy transfer [TET], e.g. inductive charging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/89—Valves
    • A61M60/894—Passive valves, i.e. valves actuated by the blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/32—General characteristics of the apparatus with radio-opaque indicia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
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    • A—HUMAN NECESSITIES
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    • A61M2205/00—General characteristics of the apparatus
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    • A61M2205/3303—Using a biosensor
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8237—Charging means
    • A61M2205/8243—Charging means by induction
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    • A61M2230/00—Measuring parameters of the user
    • A61M2230/04—Heartbeat characteristics, e.g. ECG, blood pressure modulation
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    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators
    • A61N1/3956—Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
    • A61N1/3962—Implantable devices for applying electric shocks to the heart, e.g. for cardioversion in combination with another heart therapy

Definitions

  • the second heart contacting organ 2b serves as a dolly.
  • the first and second heart contacting organs 2a,b exerts a force on the heart H from the left and right sides of the heart H which compresses the heart H and assist the pump function of the heart H .
  • Fig. 20 shows, schematically, how a piston 50 exerts force on the heart of a human patient through the connection with a heart contacting organ 2a from one side of the heart H.
  • a second heart contacting organ 2b if fixedly attached to the implantable device 1 and serves as a dolly 61 to enable the implantable device 1 to exert force on the heart H.
  • the operating device 57 could be an electric, hydraulic or pneumatic motor, and could be adapted to be controlled from outside of the human body.
  • a highly durable material could be a ceramic material, a carbon based material or a metallic material such as titanium or stainless steel.
  • parts or surfaces is made of a self lubricating material such as a fluorpolymer, alternatively the surfaces could be adapted to be lubricated by means of an implantable lubricating system.
  • the operating device 57 could be an electric, hydraulic or pneumatic motor, and could be adapted to be controlled from outside of the human body.
  • the pump device 3 is attached to a connecting arm 244 which in turn is connected to a fixating member 241 which is fixated to a structure of the human body comprising bone 240.
  • the first heart contacting organ is fixedly attached to the pump device 3 and serves as a dolly, whereas the second heart contacting organ is hinged to exert the force on the heart H.
  • Fig. 30 shows a frontal view of a human patient according to an embodiment where the implanted device 1 is an LVAD 130 (Left Ventricular Assist Device).
  • the LVAD can be fixated to a structure of the human body comprising bone 240 according to any of the embodiments described.
  • the second bellows could be used as a mechanical force transmitter or could be provided with a heart contacting organ 2 for exerting force on the heart of a human patient H.
  • the implantable system is adapted to allow free flow of fluid between said first bellows 141 and said second bellows 140.
  • Fig. 39 shows an embodiment where the heart contacting organ 2 has been moved from the position in which it is placed in fig. 38 . The position of the force exerted on the heart H is thereby moved.
  • Fig. 43 shows an embodiment where the heart contacting organ 2 is operable to change the position of the force exerted on the heart H using two operating devices 177a,b the two operating devices could be mechanical, hydraulic or pneumatic devices.
  • the heart contacting organ is operable through the connection with the operating device through the connecting arm 244 hinged to the heart contacting organ and the implantable device comprising the two operating devices 177a,b.
  • the connecting arm 244 is operable using only one operating device, in which case that operating device could be adapted for powered movement in two directions, or adapted for powered movement in one direction and spring loaded movement in the other direction.
  • Fig. 62 illustrates a system for treating a disease comprising an apparatus 10 placed in the abdomen of a patient.
  • An implanted energy-transforming device 1002 is adapted to supply energy consuming components of the apparatus with energy via a power supply line 1003.
  • An external energy-transmission device 1004 for non-invasively energizing the apparatus 10 transmits energy by at least one wireless energy signal.
  • the implanted energy-transforming device 1002 transforms energy from the wireless energy signal into electric energy which is supplied via the power supply line 1003.
  • the energy-transmission device may be controlled from outside the patient's body to release electromagnetic wireless energy, and the released electromagnetic wireless energy is used for operating the apparatus.
  • the energy-transmission device is controlled from outside the patient's body to release non-magnetic wireless energy, and the released non-magnetic wireless energy is used for operating the apparatus.
  • Fig. 74 shows an embodiment identical to that of Fig. 73 except that the implanted components are interconnected differently.
  • the internal control unit 1015 is powered by the battery 1022 when the accumulator 1016, suitably a capacitor, activates the electric switch 1023 to switch to an on mode.
  • the electric switch 1023 is in its on mode the internal control unit 1015 is permitted to control the battery 1022 to supply, or not supply, energy for the operation of the apparatus 10.
  • the system may include an external data communicator and an implantable internal data communicator communicating with the external data communicator.
  • the internal communicator feeds data related to the apparatus or the patient to the external data communicator and/or the external data communicator feeds data to the internal data communicator.
  • the feedback information may be transferred either by a separate communication system including receivers and transmitters or may be integrated in the energy system.
  • an integrated information feedback and energy system comprises an implantable internal energy receiver for receiving wireless energy, the energy receiver having an internal first coil and a first electronic circuit connected to the first coil, and an external energy transmitter for transmitting wireless energy, the energy transmitter having an external second coil and a second electronic circuit connected to the second coil.
  • the external second coil of the energy transmitter transmits wireless energy which is received by the first coil of the energy receiver.
  • Fig. 81 schematically shows an energy balance measuring circuit of one of the proposed designs of the system for controlling transmission of wireless energy, or energy balance control system.
  • the circuit has an output signal centered on 2.5V and proportionally related to the energy imbalance. The derivative of this signal shows if the value goes up and down and how fast such a change takes place. If the amount of received energy is lower than the energy used by implanted components of the apparatus, more energy is transferred and thus charged into the energy source.
  • the output signal from the circuit is typically feed to an AID converter and converted into a digital format. The digital information can then be sent to the external energy-transmission device allowing it to adjust the level of the transmitted energy.
  • Another possibility is to have a completely analog system that uses comparators comparing the energy balance level with certain maximum and minimum thresholds sending information to external energy-transmission device if the balance drifts out of the max/min window.
  • the transmission of wireless energy from the external energy source may be controlled by applying to the external energy source electrical pulses from a first electric circuit to transmit the wireless energy, the electrical pulses having leading and trailing edges, varying the lengths of first time intervals between successive leading and trailing edges of the electrical pulses and/or the lengths of second time intervals between successive trailing and leading edges of the electrical pulses, and transmitting wireless energy, the transmitted energy generated from the electrical pulses having a varied power, the varying of the power depending on the lengths of the first and/or second time intervals.
  • Fig. 86b shows a state wherein a user, such as the patient in with the apparatus is implanted, presses the regulation reservoir 1013 so that fluid contained therein is brought to flow through the conduit 1011 and into the servo reservoir 1050, which, thanks to its bellow shape, expands longitudinally. This expansion in turn expands the apparatus 10 so that it occupies its maximum volume, thereby stretching the stomach wall (not shown), which it contacts.
  • the regulation reservoir 1013 is preferably provided with means 1013a for keeping its shape after compression. This means, which is schematically shown in the figure, will thus keep the apparatus 10 in a stretched position also when the user releases the regulation reservoir. In this way, the regulation reservoir essentially operates as an on/off switch for the system.
  • the contacting area 807 could be made from a ceramic material and thereby adapted to better resist the wear that is created by the implantable device having to operate at the speed of the heart.
  • the hydraulic fluid could for example be pressurized using a hydraulic pump.
  • the system is a pneumatic system in which case the implantable device is powered by a gas compressed by a pneumatic pump.
  • the piston 801 is adapted to be moved in the opposite direction by means of spring members 805, much like the embodiment of fig. 89a , this could be needed if the piston 801 and sleeve 802 are very tightly fitted for sealing against a very high pressure since the force exerted by vacuum is limited.
  • the heart contacting organ 2 in contact with the heart 2 is a part of a heart help device adapted to assist the pump function of the heart by exerting a force on the external part of the heart.
  • This embodiment enables a fixation of the operating device 57 and the heart help device in the abdomen without having to enter the thorax outside of the pericardium P. This makes it possible to separate the thorax from the abdomen which, among other aspects, is advantageous since there is a difference in pressure between the thorax and the abdomen.
  • Fig. 94 shows a surgical or laparoscopic method of creating and maintaining a opening in the thoracic diaphragm D of a patient.
  • the method comprises the steps of: creating an incision 503 in the thoracic diaphragm D and thereby creating a opening 503 in the thoracic diaphragm D, placing a diaphragm contacting part 501 in contact with the thoracic diaphragm D, thereby maintaining the opening 501 created in the thoracic diaphragm D.
  • Fig. 94 further shows a section of a heart help device comprising a heart contacting organ 2, a connection arm 244, a fixation plate 242 and a screw 243 for fixation of the fixation plate 242.
  • connection arm 244 is bent such that said connecting arm 244 is adapted to fixate a heart help device to a part of the human body comprising bone through the diaphragm contacting part 501 maintaining an opening in the thoracic diaphragm D.
  • Fig. 98 shows the implantable heart help comprising the elements of the heart help device disclosed with reference to fig. 97a .
  • the heart contacting organs 502a,b of fig. 98 further comprises hydraulic or pneumatic cushions 171 adapted to exert force on the heart H.
  • the hydraulic or pneumatic cushions 171 could change to alter the area of the heart H to which force is exerted.
  • the cushions comprises chambers having a volume and the size of that volume is adapted to be changeable individually, for each cushion to influence the force exerted on the heart H after the implantable heart help device has been implanted in the patient.
  • the hydraulic or pneumatic cushions have volumes adapted to be changed using an implantable hydraulic or pneumatic system 519, according to this embodiment adapted to be placed in the abdomen of the patient.
  • Fig. 101a-d shows an embodiment of the diaphragm contacting part disclosed in several embodiments throughout the application.
  • the diaphragm contacting part of fig. 101a is a diaphragm contacting part adapted to be opened to enable the insertion of force transferring members or diaphragm passing parts.
  • the diaphragm contacting part comprises an outer section 509 which is adapted to engage the edges of an opening created in the thoracic diaphragm.
  • the edges 507 of the thoracic diaphragm could clamp the thoracic diaphragm and thereby assist in the fixation of the diaphragm contacting part to the thoracic diaphragm and/or to the pericardium.
  • Fig. 113 shows a flow-chart of an operation method which could comprise the steps of: 1) dissecting a part of the human body comprising bone and 2) fixating a fixating member to the bone, such that the fixation member is placed in contact with the connection arm.
  • the method further comprises the steps of 3) creating an opening in the thoracic diaphragm and 4) inserting the connecting arm into the thorax through the opening in the thoracic diaphragm.
  • This diaphragm approach enables a surgeon to place a heart help device in the pericardium of thorax without opening the thorax.
  • the method could further comprise the step of placing an operation device in the abdomen of the patient, transferring force to through an opening in the thoracic diaphragm and into the thorax for operating a heart help device placed in thorax.

Claims (13)

  1. Implantierbare Vorrichtung (1) zum Verbessern der Pumpfunktion des Herzes (H) eines menschlichen Patienten durch Ausüben einer externen Kraft auf den Herzmuskel, wobei die Vorrichtung gekennzeichnet ist durch Umfassen wenigstens einer Pumpvorrichtung (3) umfassend:
    • eine erste Platte (11) mit einer ersten Oberfläche und
    • eine zweite Platte (12) mit einer zweiten Oberfläche, wobei
    ∘ die erste Platte bezogen auf die zweite Platte verschiebbar ist,
    ∘ die erste Oberfläche im Wesentlichen parallel zu der zweiten Oberfläche ist,
    ∘ die erste und die zweite Oberfläche dafür ausgelegt sind, wenigstens zum Teil aneinander anzuliegen und
    ∘ die erste und/oder zweite Platte Spulen (14) umfasst und die erste und/oder zweite Platte Magneten (15) umfasst,
    ∘ die Verschiebung der ersten Platte durch schrittweise Erregung der Spulen erzeugt wird, und wobei
    ∘ die erste Platte, wenn implantiert, direkt oder indirekt eine Kraft auf einen externen Teil des Herzmuskels ausübt.
  2. Implantierbare Vorrichtung gemäß Anspruch 1, wobei die erste Platte wenigstens eines von: bezogen auf die zweite Platte drehbar und bezogen auf die zweite Platte hin- und hergehend verschiebbar ist.
  3. Implantierbare Vorrichtung gemäß einem der Ansprüche 1 und 2, wobei das schrittweise Erregen von außerhalb des Körpers des Patienten durchgeführt werden könnte.
  4. Implantierbare Vorrichtung gemäß einem der vorstehenden Ansprüche, wobei die Pumpvorrichtung ferner einen zentralen Schaft (17) umfasst, der dafür ausgelegt ist, die Verschiebung der ersten Platte bezogen auf die zweite Platte zu führen.
  5. Implantierbare Vorrichtung gemäß einem der vorstehenden Ansprüche, wobei die Pumpvorrichtung eine Antriebsvorrichtung (57) und ein Kraftübertragungselement (59) umfasst, wobei die Antriebsvorrichtung die erste Platte umfasst und wobei die erste Platte mit dem Kraftübertragungselement verbunden ist, um Kraft von der Antriebsvorrichtung auf das Kraftübertragungselement zu übertragen, um direkt oder indirekt Kraft auf einen externen Teil des Herzmuskels auszuüben.
  6. Implantierbare Vorrichtung gemäß Anspruch 5, wobei das Kraftübertragungselement dafür ausgelegt ist, Kraft von der abdominalen Seite des thorakalen Diaphragmas auf die thorakale Seite des thorakalen Diaphragmas zu übertragen.
  7. Implantierbare Vorrichtung gemäß einem der vorstehenden Ansprüche, wobei die Vorrichtung ferner eine dritte Platte (13) umfasst, die dafür ausgelegt ist, an der zweiten Platte anzuliegen, und wobei die erste und die dritte Platte Magneten (15) umfassen und wobei die zweite Platte Spulen umfasst, und wobei die erste und die dritte Platte dafür ausgelegt sind, durch Erregung der Spulen der zweiten Platte bezogen auf die zweite Platte verschiebbar zu sein.
  8. Implantierbare Vorrichtung gemäß einem der vorstehenden Ansprüche, wobei die Pumpenvorrichtung dafür ausgelegt ist, an wenigstens einem von: dem Brustbein, wenigstens einer Rippe, wenigstens einem Wirbelkörper und einem anderen Teil des menschlichen Körpers, der Knochen umfasst, befestigt zu werden.
  9. Implantierbare Vorrichtung gemäß einem der vorstehenden Ansprüche, wobei wenigstens eines von: der Vorrichtung, der ersten Platte und der zweiten Platte wenigstens eines von: einem keramischen Material, einem Kohlenstoffmaterial und einem metallischen Material umfasst.
  10. Implantierbare Vorrichtung gemäß einem der vorstehenden Ansprüche, wobei die medizinische Vorrichtung ferner ein mit dem Herz in Kontakt stehendes Element (2) in direktem Kontakt mit dem Herz und in direktem oder indirektem Kontakt mit wenigstens einem von: der ersten Platte und der zweiten Platte umfasst.
  11. Implantierbare Vorrichtung gemäß Anspruch 10, wobei das mit dem Herz in Kontakt stehende Element dafür ausgelegt ist, eine externe Kraft auf wenigstens eines von: dem linken Ventrikel des Herzes, zwei verschiedenen Seiten des linken Ventrikels des Herzes, dem rechten Ventrikel des Herzes und zwei verschiedenen Seiten des rechten Ventrikels des Herzes auszuüben.
  12. System, umfassend eine Vorrichtung gemäß einem der vorstehenden Ansprüche, umfassend einen internen Energieempfänger (1002), der dafür ausgelegt ist, nichtinvasiv und drahtlos von einer Energieübertragungsvorrichtung (1004) von außerhalb des Körpers des Patienten erregt zu werden, die dafür ausgelegt ist, drahtlose Energie zu wenigstens einem von:
    • einer implantierbaren internen Energiequelle gemäß einem der vorstehenden Ansprüche, die durch die von der Energieübertragungsvorrichtung übertragenen Energie aufladbar ist, und
    • wenigstens einer implantierbaren energieverbrauchenden Komponente der Vorrichtung, die mit der drahtlosen Energie erregt wird,
    zu senden.
  13. System, umfassend eine Vorrichtung gemäß einem der Ansprüche 1-11 und das System gemäß Anspruch 12, umfassend einen Sensor und/oder eine Messvorrichtung, die wenigstens eines von: wenigstens einem physischen Parameter des Patienten und wenigstens einem funktionellen Parameter, der mit der Vorrichtung verbunden ist, umfassend wenigstens eines von: einem funktionellen Parameter, der mit der Energieübertragung zum Aufladen der internen Energiequelle gemäß Anspruch 12 korreliert, und einem anderen funktionellen Parameter, der mit der Vorrichtung verbunden ist, erfasst oder misst, wobei
    die Vorrichtung ferner eine Rückmeldungsvorrichtung (1025) zum Senden von Rückmeldungsinformation von innerhalb des Körpers des Patienten zu wenigstens einem von:
    - einer implantierbaren internen Steuereinheit (1015) und
    - dem Außenraum des Körpers des Patienten,
    umfasst, wobei die Rückmeldungsinformation mit wenigstens einem von: dem wenigstens einen physischen Parameter des Patienten und dem wenigstens einem funktionellen Parameter, der mit der Vorrichtung verbunden ist, verbunden ist.
EP09819466.5A 2008-10-10 2009-10-12 Herzunterstützungsgerät und system Active EP2349382B1 (de)

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SE0802143 2008-10-10
SE0802139 2008-10-10
SE0802142 2008-10-10
SE0802140 2008-10-10
SE0802144 2008-10-10
SE0802141 2008-10-10
US20238009P 2009-02-24 2009-02-24
US20238309P 2009-02-24 2009-02-24
US20238209P 2009-02-24 2009-02-24
US20240509P 2009-02-25 2009-02-25
US20240709P 2009-02-25 2009-02-25
US20240409P 2009-02-25 2009-02-25
US20240609P 2009-02-25 2009-02-25
US20239309P 2009-02-25 2009-02-25
PCT/SE2009/000449 WO2010042012A1 (en) 2008-10-10 2009-10-12 Heart help device, system, and method

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EP09819463.2A Active EP2349381B1 (de) 2008-10-10 2009-10-12 Herzunterstützungsgerät, system und verfahren
EP09819473.1A Active EP2346548B1 (de) 2008-10-10 2009-10-12 Herzunterstützungsvorrichtung und system
EP21177024.3A Pending EP3909559A1 (de) 2008-10-10 2009-10-12 Vorrichtung und system zur herzunterstützung
EP19214928.4A Pending EP3689318A1 (de) 2008-10-10 2009-10-12 Herzunterstützungsgerät und system
EP09819467.3A Active EP2349383B1 (de) 2008-10-10 2009-10-12 Herzunterstützungsgerät und system
EP19214931.8A Pending EP3708136A1 (de) 2008-10-10 2009-10-12 Herzunterstützungsgerät, system und verfahren
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EP21177024.3A Pending EP3909559A1 (de) 2008-10-10 2009-10-12 Vorrichtung und system zur herzunterstützung
EP19214928.4A Pending EP3689318A1 (de) 2008-10-10 2009-10-12 Herzunterstützungsgerät und system
EP09819467.3A Active EP2349383B1 (de) 2008-10-10 2009-10-12 Herzunterstützungsgerät und system
EP19214931.8A Pending EP3708136A1 (de) 2008-10-10 2009-10-12 Herzunterstützungsgerät, system und verfahren
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US11771907B2 (en) 2023-10-03
US20180021493A1 (en) 2018-01-25
US10556047B2 (en) 2020-02-11
US11224735B2 (en) 2022-01-18
AU2022200238A1 (en) 2022-02-10
EP2349381A4 (de) 2016-11-16
AU2017202799A1 (en) 2017-05-18
US20230405333A1 (en) 2023-12-21
AU2018271406A1 (en) 2018-12-20
AU2018271406B2 (en) 2020-03-05
EP3909559A1 (de) 2021-11-17
US20170065756A1 (en) 2017-03-09
WO2010042012A1 (en) 2010-04-15
US20170065754A1 (en) 2017-03-09
US9440014B2 (en) 2016-09-13
US9925318B2 (en) 2018-03-27
US20150343125A1 (en) 2015-12-03
US20220218977A1 (en) 2022-07-14
HRP20211570T1 (hr) 2022-04-01
EP2346548A1 (de) 2011-07-27
EP3925660A1 (de) 2021-12-22
EP2349382A1 (de) 2011-08-03
US20110201871A1 (en) 2011-08-18
EP2349383A4 (de) 2016-09-28
US20110196483A1 (en) 2011-08-11
EP2349381B1 (de) 2019-12-11
EP2349381A1 (de) 2011-08-03
US9364595B2 (en) 2016-06-14
WO2010042011A1 (en) 2010-04-15
US9072907B2 (en) 2015-07-07
US10786609B2 (en) 2020-09-29
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US20190099531A1 (en) 2019-04-04
PL2349383T3 (pl) 2022-09-19
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US20140296613A1 (en) 2014-10-02
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US9731055B2 (en) 2017-08-15
SI2349383T1 (sl) 2022-02-28
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US9005104B2 (en) 2015-04-14
US8696745B2 (en) 2014-04-15
US20210196942A1 (en) 2021-07-01
US9457137B2 (en) 2016-10-04
US20200353139A1 (en) 2020-11-12
US20200246522A9 (en) 2020-08-06
US20140135568A1 (en) 2014-05-15
US20170021073A1 (en) 2017-01-26
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US20160030651A1 (en) 2016-02-04
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US8469874B2 (en) 2013-06-25
EP2346548A4 (de) 2016-09-28
EP2346548B1 (de) 2021-06-16
US20110224787A1 (en) 2011-09-15
WO2010042019A1 (en) 2010-04-15

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